GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

{0}------------------------------------------------ FINGE Clastle Getinge/Castle, Inc. 7371 Spartan Blvd., East North Charleston, SC 29418 ಳು ﺎﺕ ﺍﻟﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ Tei 803.552.8652 Fax 803.552.8652 | (1) | Submitters Name | Getinge/Castle, Inc. | |-----|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Submitters Address | 7371 Spartan Blvd., East<br>North Charleston, SC 29418 | | | Submitters Telephone No. | (803) 552-8652 | | | Contact Name | Trevor Williamson | | | Summary Preparation Date | October 3, 1997 | | (2) | Device Name | Getinge/Castle OptiView® Surgical Light | | | Common or Usual Name | Surgical Light | | | Classification Name | Surgical Lamp | | (3) | Predicate Device(s) | ALM Prismatic®, model 7001 and 9001 series<br>AMSCO SQ240<br>Berchtold Chromophare®, model C-570, C-570/570 and C-570/570/570 | | (4) | Device Description | The Getinge/Castle OptiView® surgical lights are designed to<br>provide the high quality light required in an operating room<br>setting.<br>There are four major considerations that the lights have been<br>designed for:<br>1. Shadow Elimination. 144 radial dioptric lenses, disposed<br>equally on the lens glass, are used to broaden the light<br>beam such that a 10 X 20 cm patch of light is produced on<br>the surgical site from each lens. Should one or several of<br>the lenses become obstructed by the surgeon or from<br>equipment, a constant quantity of light is subtracted from<br>each point of the light field. This virtually eliminates<br>shadows and provides for optimum visibility.<br>2. Optimal Depth of Field. A central toric lens and conic<br>mirror is used to produce very broad beams whose<br>intersection are not points but are volumes. In some cases<br>the volume can measure up to 70 cm in height and 20 cm<br>across the center. The design also allows the volume of<br>light to be moved in the axis of the beam, this is called<br>variable focusing.<br>true<br>3. Heat Elimination and High Color Rendition. Through the<br>use of a special type of glass, the emitted light is corrected<br>for color (towards the model for broadband sunlight) and<br>filtered for infrared. This eliminates the thermal effect of<br>the beam and allows a color rendition index of Ra = 95 or<br>greater. | {1}------------------------------------------------ *GETINGE Lancer Getinge/Castle. Inc. 7371 Spartan Blvd.. East North Charleston, SC 29418 Tel 803.552.8652 Fax 803.552.8652 - Electromagnetic and Bacteriologic Neutrality. The product 4. Device Description (con't) (4) have been designed and tested to comply with the strictest electromagnetic compatibility standards. Also, the sealed optical unit, the flat, smooth surfaces and sensitive touch-controls orovide for an extremely aseptic environment. The mechanical aspects of the lights are that they are constructed of specifically designed steel load-bearing drop tubes, yokes and suspension assemblies that are coated with a strong epoxy resin paint. These structures are mechanically connected at pivot points that incorporate counter-balances for ease of movement as well as specially designed wire-runs and fully pivoting electrical connectors. The electrical aspects of the lights are designed* to comply with international safety standards such as: ഗ് Low Voltage Directive (LVD) 72/23/CEE, Decree No. 95-1081 Directive (EMC) 6. Electromagnetic Compatibility 89/336/CEE, Decree No. 95-587 Device Directive (MDD) 93/42/CEE. Power 7. Medical Supply Units, NF EN 60-4391 (IEC 433-1), NF EN 60-439-Operating Theatre Lighting, NF EN 60-601-1 (IEC 601) 8. The design will also be examined to UL 544 and certified by either Underwriters Laboratory or Intertek Testing Services (ITS) which should result in the UL or ETL mark. *NOTE: The lights were previously CE marked, while marketed in Europe, by the original manufacturer: Scialityque Industrie. The lights are electrically controlled via pressure sensitive touch controls that may be located on the lights or at remote locations. The controls allow the lights to be energized, the light level to be adjusted and the focus mechanisms to be operated. The light beam is achieved through the use of one or two (dependent upon model) tungsten-halogen 24 VDC bulbs that are contained in a sealed optical unit. The emitted light is focused through a toroidial lens and is reflected off of a conic. polished aluminum reflector and through 144 radial dioptric lenses which allows for a radial-focused broad-beam light pattern on the surgical surface. This eliminates shadows while concurrently extending the true depth of field of the beam. {2}------------------------------------------------ *GETINGE asdc Getinge/Castle, Inc. 7371 Spartan Blvd., East North Charleston, SC 29418 | (5) | Statement of Intended Use | The Getinge/Castle OptiView Surgical Lights are to be used<br>in the same, (general type and configuration), surgical<br>operatory theatres, and out-patient surgery centers that<br>currently employ various models of the referenced predicate<br>devices. | |-----|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (6) | Summary of Similar Technology | See attached product comparison tables. The specific models<br>shown in the tables were chosen on the basis of the similarity<br>of the lamp head designs, illumination and other performance<br>data. | The OptiView® 500 series lights are identified as follows: | Model | Description | Predicate | |-------|----------------------------------------------------------------------------------|-----------------------------------------| | 500 | Ceiling mount - one (1) 500 series lamp head | ALM PRC 7001, Berchtold C-<br>570/570 | | 525 | Ceiling mount - one (1) 200 series lamp head and one (1)<br>500 series lamp head | ALM PRC 7001, Berchtold C-<br>570/570 | | 550 | Ceiling mount - two (2) 500 series lamp heads | ALM PRC 5501 DF, Berchtold<br>C-570/570 | | 555 | Ceiling mount - three (3) 500 series lamp heads | ALM PRC 5551, Berchtold C-<br>570/570 | | 590 | Floor stand mount - one (1) 500 series lamp head | ALM PRC 7001, Berchtold C-<br>570/570 | The OptiView® 700 series lights are identified as follows: | Model | Description | Predicate | |-------|-----------------------------------------------------------------------------------|--------------------------------------------------------------| | 700 | Ceiling mount - one (1) 700 series lamp head | ALM PRC 9001, AMSCO<br>SQ240, Berchtold C-<br>570/570/570 | | 750 | Ceiling mount - one (1) 500 series lamp head and one (1)<br>700 series lamp head | ALM PRC 9501 DF, AMSCO<br>SQ240, Berchtold C-<br>570/570/570 | | 755 | Ceiling mount - two (2) 500 series lamp heads and one<br>(1) 700 series lamp head | ALM PRC 9551, AMSCO<br>SQ240, Berchtold C-<br>570/570/570 | The basic assumptions that we are basing this pre-market notification on, and why we believe that the GetingelCastle OptiView® Surgical Light is substantially equivalent to the predicate devices, is that we believe that: - We are not introducing new technology. The OptiView® lights and the predicate devices use very similar . technology to achieve the same basic goal; to illuminate the patient area and concentrate light at the surgical incision with deep cavity penetration. The use of the toric lens, conic reflector and radial dioptric lens in the 500 and 700 series has been standard practice for Scialytique (the original manufacturer) for over ten (10) years in Europe. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "GETINGE" in bold, black letters next to a star-like symbol. To the right of "GETINGE" is another word that is difficult to read due to the image quality, but it appears to end in "...tic". The background is white behind "GETINGE" and the star, but it is black behind the other word. The overall impression is that this is a logo or brand name. Getinge/Castle. Inc. 7371 Spartan Blvd., East North Charleston, SC 29418 Tel 803.552.8652 Fax 803.552.8652 - We are not introducing new or radical manufacturing methods. The Getinge/Castle OptiView® surgical lights . will be manufactured using production methods readly available to the general medical device industry. These practices are already in use for existing domestically marketed products and will be used for the manufacture of the OptiView® 500 and 700 series lights. - We are not introducing any new indications for use. As stated earlier, the GetingelCastle OptiView® surgical . lights are to be used for the same purposes and in the same manner as the predicate devices. The lights will be used as the primary and secondary methods of illuminating areas of the human body such that deep cavities can be penetrated and shadows eliminated during surgical procedures. Our intended customer base includes various health care professionals working in medium to large operatory settings. We consider the OptiView® lights to be a single product line and we intend to market them in that manner. We have included them together for this notification because we believe that, like the ALM Chromophare® product line, which incorporates several different lamp head configurations under the same FDA clearance number, the Optiview lights are contemporary and complimentary to each other. These lights will be used in different configurations as stand alone units but also will be combined together (i.e. the 500 series lamp paired with a 700 series lamp on the same suspension package) for total operatory coverage. {4}------------------------------------------------ ## Getinge/Castle Getinge/Castle Additional Information in Support of K974084 ## Part 2: Predicate devices for the Optiview Series 200, with the requested specifications: | Specification | Optiview 200 Series | Model<br>ALM Illuminator<br>Spotlight | Berchtold Chromophare<br>C-300 | |------------------------------------------------------|-------------------------------|---------------------------------------|-----------------------------------------------| | Diameter, cm (in) | | | | | Lens | 230 (9.0) | Not specified | 365 (10.4) | | Lighthead | 316 (12.4) | 330 (13) | 300 (11.8) | | Weight, kg (lb.) | 2.5 (5.5) | Not specified | Not specified | | Mounting Type | Wall, Ceiling, Floor<br>Stand | Wall, Ceiling, Floor<br>Stand | Wall, Ceiling, Floor<br>Stand | | Supply Voltage, VAC | 120/230 | 120 | 110/220 | | Power, W | 55 | 150 | 55 | | Bulb, Type | Tungsten Halogen | Quartz Halogen | Halogen | | Volts | 24 | Not specified | 24 | | Life, hr | 500 | Not specified | Approx. 1000 | | Number of Light Heads | 1 | 1 | 1 | | Number of Bulbs | 1 | 1 | 1 | | Color Temp. °K | 4300, Nominal | Not specified | 4500 | | Field Size, cm (in) | | | | | Diameter | 100-150 (3.9-5.9) | Not specified | 170 (6.7) | | Depth | 400 (15.7) | Not specified | Not specified | | Focal Length, cm (in) | 350 (13.8) | Not specified | Not specified | | Illumination Level, ft-<br>candles (Lux) | 5,670 (61,000) at<br>4300°K | 3717 (40,000) | 3253 (35,000) | | Controls | | | | | Dimmer | Variable Intensity | Not specified | Not specified | | Volts | 24 | Not specified | 24 | | Focus | Adjustable | Not specified | Adjustable | | Field Size | Adjustable | Not specified | Adjustable | | Rotation, ° | 360 | Not specified | 360 | | Vertical Adjustment<br>Range, cm (in) | 1792 (70.5) | Not specified | 1190 (46.9) | | Heat Filtering, % | 99 | Not specified | Not specified | | Filter Material | Glass | Not specified | Yes | | Reflector Material | Polished Aluminum | Not specified | Not specified | | Satellites | Optional | Optional | Not specified | | Sterilizable Handle | Yes | Not specified | Not specified | | Min. Ceiling Height,<br>cm (in) | 2591 (102) | Not specified | Not specified | | Spec.<br>Model | OptiView®,<br>500 series | ALM, PRC 7001<br>series | Berchtold, C-570<br>series | | Diameter, cm (in) | 44.3 (17.5) | 71.1 (28) | 50 (20) | | Lens | 54.2 (21.3) | 71.1 (28) | 57 (22.5) | | Lighthead | 12 (26.4) lamp<br>head only | 73.9 (163) lamp<br>head only | 63 (138) single,<br>95 (209) dual | | Weight, kg (lb.) | Ceiling, wall,<br>floor stand | Ceiling | Ceiling, wall, floor<br>stand | | Mounting Type | 120/230 | 120 | 120/230/240 | | Supply Voltage,<br>VAC | 140 | 240 | 150 | | Power, W | Tungsten<br>Halogen | Quartz Halogen | Xenon Halogen | | Bulb, Type | 24 | 24 | 24 | | Volts | 500 (min) | 1000 | 1000 | | Life, hr | 1, 2 or 3 | 1 | 1,2 or 3 | | Number of Light<br>heads | 1 or 2 | 2 | 1 main, 1 reserve | | Number of Bulbs | 4,300 | 3,500 | 4,500 | | Color Temp, °K | | | | | Field Size, cm (in) | 10-15 (3.9-5.9) | 20.3 (8) | 18-28 (7-11) | | Diameter | 40 (15.7) | 70 (27.6) | 80 (31) | | Depth | 90-140 (35-55) | Not specified | 70-140 (27.5-55) | | Focal Length, cm<br>(in) | 12,300 (130,000) | 9,300 (100,000) | 9,300 (100,000)<br>13,530 (145,000) | | Illumination Level,<br>max ft-candles (lux) | | | | | Controls | Variable intensity | Continuous | Continuous | | Dimmer | 24 | 120 | 120 | | Volts | Adjustable | Fixed | Adjustable | | Focus | Adjustable | Fixed | Adjustable | | Field Size | 360 | 360 | 360 | | Rotation, ° | 122.6 (48.3) | 83.8 (33) | 115 (45) | | Vert. Adjustment<br>Range, cm (in) | 99 | Not specified | 99 | | Heat Filtering, % | Glass | Glass | Glass/film | | Filter Material | Aluminum | N/A (refracted<br>through prisms) | Aluminum | | Reflector Material | Optional | Optional | Optional | | Satellites | Yes | Yes | Yes | | Sterilizable Handle | 245 (100) | 264.2 (104) | 260 (102) | | Min. Ceiling Height,<br>cm (in) | | | | | Model<br>Spec. | OptiView®,<br>700 series | ALM, PRC 9001<br>series | AMSCO, SQ240 | | Diameter, cm (in) | | | | | Lens | 58.5 (23) | 91.4 (36) | 55.9 (22) | | Lighthead | 75.6 (29.8) | 91.4 (36) | 60.9 (24) | | Weight, kg (lb.) | 28 (61.6) | 21.8 (48) light unit<br>only | 67 (148) single,<br>113 (250) dual | | Mounting Type | Ceiling | Ceiling | Single or dual arm,<br>track, optional AV arm | | Supply Voltage,<br>VAC | 120/230 | 120 | 120 | | Power, W | 140 | 120 | 220 | | Bulb, Type | Tungsten Halogen | Quartz Halogen | Quartz Halogen | | Volts | 24 | 24 | 22 | | Life, hr | 500 (min) | 1000 | 1000 | | Number of Light<br>heads | 1,2 or 3 | 1 | 1,2 or 3 | | Number of Bulbs | 1 or 2 | 3 | 1 main, 1 reserve per<br>lighthead | | Color Temp, °K | 4,300 | 3,500 | 4,200; 4,400 | | Field Size, cm (in) | | | | | Diameter | 17-24 (6.7-9.4) | 20.3 (8) | 16.5 (6.5); 17.8 - 21.6<br>(7-8.5) | | Depth | 50 (19.7) | 70 (27.6) | 66 (26) | | Focal Length, cm<br>(in) | 50 (19.7) | Not specified | 106.7 (42) | | Illumination Level,<br>max ft-candles<br>(lux @ 1 m) | 11,200 (120,000) | 11,160 (120,000) | 10,000 (107,640)<br>12,000 (129,170 | | Controls | | | | | Dimmer | Variable intensity | Continuous | Variable intensity | | Volts | 24 | 120 | 24 | | Focus | Adjustable | Fixed | Fixed | | Field Size | Adjustable | Fixed | Adjustable | | Rotation, ° | 360 | 360 | 360 | | Vert. Adjustment<br>Range, cm (in) | 122.6 (50) | 134.6 (53) | 74.9 - 200.1 (29.5 -<br>79) | | Heat Filtering, % | 99 | Not specified | 98 | | Filter Material | Glass | Glass | Cold/hot mirror; cold<br>mirror | | Reflector Material | Aluminum | N/A (refracted through<br>prisms) | Plastic | | Satellites | Optional | Optional | Optional | | Sterilizable Handle | Yes | Yes | Yes | | Min. Ceiling Height,<br>cm (in) | 245 (100) | 281.9 (111) | 257.8 (101.5) single<br>269.2 (106) dual | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for GETINGE, a company that provides equipment and systems for the healthcare and life sciences industries. To the left of the company name is a star-like symbol. To the right of the company name is the word "Castle" in a smaller font. ﺎ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ ## OptiView® 500 series vs. Predicate Devices {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for GETINGE and Listic. The GETINGE logo is a stylized asterisk followed by the word "GETINGE" in bold, sans-serif font. To the right of GETINGE is the word "Listic" in a smaller, less distinct font. ## OptiView® 700 series vs. Predicate Devices {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human figures, possibly representing health and well-being. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 3 Mr. Peter L. Koste, Jr. benior Manager, Quality Assurance and Regulatory Affairs Getinge/Castle, Incorporated 7371 Spartan Boulevard, East (29418) P.O. Box 40488 North Charleston, South Carolina 29423-0488 Re: K974084 Getinge/Castle Optiview Series Surgical Trade Name: Light Regulatory Class: II Product Code: FSY January 27, 1998 Dated: Received: February 13, 1998 Dear Mr. Koste: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {8}------------------------------------------------ Page 2 - Mr. Koste This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, fcella coll Celia M. Witten, Ph.D., M.D. Director Division of Coporal and Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ 003 510(k) Number (if known): K979084 Device Name: Officient Sungican 61514 Indications For Use: THE PRODUCT UNIL BE USED TO ILLUMNATE SURGICAL PROCEDURES WITH COLOR CORRECTED ITE LIGHT AND HEAT FILTERING (FF.). DESIGNED TO ELIMINATE SHADOWS AND 14 DEEP CALITY COUNDS WITH ADGRATE VENEFRATE 61947 115 IS INTENDED TO BE USED 137 THE PRODUCT SURGEONS AND OTHER MEDICIN CARE PRACTICING OF THERE ARE NO IN A SURGICAL SETTING FOR USE. CONTRA-INDICATIONS (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K974084 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Formal 1-2-96) D